Navigating the Chaos

This quote from best-selling author and business guru Tom Peters’ Thriving On Chaos could have been written for pharma right now.

Megatrends disrupt the landscape, while political and economic uncertainties make predicting the future a fool’s game. Chaos is everywhere, not least in patient access.

How companies respond may well have a lot to do with that eternal question – is the glass half-full or half-empty?

“I like the uncertainty that chaos brings in filling up that glass,” says John A. Bardi, VP, Public Affairs and Digital Medicine Business Development, at Otsuka. “Business performance uncertainty facing all US healthcare ecosystem stakeholders requires leaders to anticipate better, think smarter, pivot more quickly, and be open to experimenting with new market approaches based on the generation of real-world evidence (RWE) about our products. Meaningful

RWE is clearly emerging as a new norm necessary for securing patient and prescriber access to our products.”

The value of R&D
A scientist by training, Debbie Drane, SVP, Commercial Development, at CSL Behring, can understand the reluctance of scientists to engage in discussions around value. “My research guys are still struggling. [They say:] “But it really works” or “It’s going to fit an unmet need.” But when I ask, “Yes, but what’s the value to the patient or the physician or the payer?” they can’t speak that language.”

Yet, pharma must find a way to embed a culture of value. “There must be ways that we can do this better, to take costs out of the whole lifecycle from early-stage research right through to post-launch, bringing value to the table throughout every step of the way,” she says.

The time for action is now, says Michelle Hoiseth, Corporate VP, PAREXEL. “For the first time, rare disease therapies are not going to get reimbursed at their intended launch pricepoint. That’s a huge wake-up call. What does that tell us? How do we expect that to flow backwards so we’re better able to demonstrate value and outcomes during development?”

Also a scientist, she comes at the problem from the point of view of study operations. “When we’re having this discussion, I gravitate towards how I can get my earlier-phase developers to think differently about the kind of evidence we need to generate and how we are defining value for the population? The challenge is trying to help them to navigate the tension between optimizing protocol designs, streamlining the data we collect, controlling clinical study cost and adding endpoints that identify value.”

The solution is moving beyond the “lock-step drug development paradigm”, she says. “We’re demonstrating safety first, then safety and efficacy in a very controlled population, and now, all of a sudden, we’re in negotiations with payers. My plea is to break down the phased development approach.”

“We must not only accept a change in our thinking, but embrace it” says Bardi. “What is clear, regardless of therapeutic area of focus, is that the days of developing pharmaceutical products solely on the basis of filling a gap in unmet medical need, and pricing them without regard to evidence-based value, are behind us.”

Collaborate or dieInternal change is vitally important but shaping the external environment is paramount, says Joseph Dye, Head of HEOR, Neurology US, at UCB.

“We have to find a willing and capable partner to work with, especially if we’re going to talk about creative contracting. We have to engage the patients in this process; we are continuously leaving them out in terms of [defining] what is value to the patient. It won’t be a one sizefits-all solution so we’re going to have to work together, because it’s going to take more than one contract to get this right. We have to work for that win win-win situation, where there’s room for everybody.”

Any collaborations must be broad, says Drane. “Personally, I’m excited; there’s so much data around now, so it’s about how we can capture it, use it and bring everyone – patients, physicians, payers, pharmaceutical industry, the four Ps – to the same table, as well as politicians and maybe the FDA, to have a good outcome.”

Bardi agrees: “Without a collaborative evidencegeneration mindset between our scientific and payer stakeholders, business performance uncertainty for our products will continue. Ongoing pressure to get this mindset in action and payer stakeholders aligned must continue as political and regulatory stakeholders are keeping a watchful and critical eye on pharmaceutical pricing.”

Is pharma’s role to facilitate dialogue between payers and regulators? “The conversations we have with clinical colleagues are robust but if we could bring the payers and the regulators together...” muses Drane. “There are just so many payers in this country, it’s almost mindboggling how many there are, but maybe we could bring together at least the CMS and some of the big government ones [to] get a better dialogue between the regulator and the payer.”

They do it in Europe, she says. “You have joint parallel advice and maybe that’s something that we can try as an industry to encourage the FDA to encourage the payers.”Bardi strikes a cautious note. “Let free market dynamics do their job as the pharmaceutical manufacturers and the payers collaborate around a new mindset and a new set of standards for establishing the value of pharmaceuticals in delivering clinically meaningful patient outcomes and reductions in total cost of care. There is no need for government interference in negotiating drug pricing or directing the requirements for value evidence standards.”

Dye leans on his experience as a consultant. “The collaboration model worked really well where we had the payer sitting at the table with the pharmaceutical company client, with the consulting team at the table to agree on what question to ask, what data to use to answer it, and how the project was going to be run, agreeing that all the results are on the table. Whether it goes the way you hope or not, it’s all on the table for both sides to see. That’s a very strong model to use, moving forward.”

There may well be partners out there able to intermediate, says Hoiseth. “The government can’t negotiate? Yet, if we could take advantage of that incredibly large payer body we could influence change. So, is there a proxy? Is there a group in the highly fragmented payer environment here in the US that we can focus on as a group to try that can act as a bridge?”

The bigger picture
Pharma has a hard time demystifying the total healthcare cost of any given disease, says Hoiseth. “If we all believe that therapies, drugs and treatments are about 10% of the cost of care and we allow the public discourse to be about reducing those costs, we will have done very little to reduce the total cost of care associated with disease.

“We need to do a better job quantifying the impact that therapies have on the cost of care. Wouldn’t it be amazing if we began to develop therapies with an eye towards solving a particularly huge cost driver, which is almost always tied to an outcome or quality of life issue for our patients? Would that help our scientist connect with the determination of value?”

Improving diagnoses is one way to stop costs spiralling, says Drane. A fact she is acutely aware of working in the rare disease space. “A lack of diagnoses costs the system a lot of money because patients are jumping from physician to physician because no one knows what their problem is. If we could improve diagnoses; get more precision into that end of the spectrum, we could take money out of the system.”

Yet, coming full circle, companies do not always have the evidence they need to engage payers in conversations about holistic value. “I was in a recent payer meeting and the question came up,” says Dye. “[They said:] ‘We’re really interested in doing something that addresses the total cost of care, so let’s start there’. I was thinking, ‘Oh, wow!’ We had some evidence that alludes to that but if that’s the question on the table when you walk in the room, we’re not always well-equipped to answer the question.

We can pick away at the edges [of costs] in many cases but getting right to the heart of a matter – what is this going to do for the total cost of care for this group of patients? – that could be a difficult conversation.”

Taking a step backwards to the larger question of how to navigate the chaos, Drane sees only one solution. “To make a real impact, industry is going to have to get together, and not try to solve our own little problems alone, [rather] solve bigger problems together. If we can’t find a way to do that I don’t think you can rely on the government to fix it all because it’s too much. It’s just too chaotic and complicated; I don’t think any government could fix it, not even one as big and as strong as the US.”

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